RADIESSE 0.8 CC, RADIESSE 1.5CC, RADIESSE 3.0CC
FDA premarket approval P050037/S052 · decided 2014-08-19
Approval details
- PMA number
- P050037
- Supplement
- S052
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RADIESSE 0.8 CC, RADIESSE 1.5CC, RADIESSE 3.0CC
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Merz North America, Inc.
- Date received
- 2014-07-23
- Decision date
- 2014-08-19
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franksville, WI
- Statement
- RELOCATION OF THE QUALITY INCOMING INSPECTION LAB, INSTALLATION OF THE QC CLEAN ROOM AND INSTALLATION OF AN AUTOMATED TEMPERATURE/HUMIDITY MONITORING SYSTEM.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DESCRIBE PFD Patch (K172689) | Merz North America, Inc. | 2017-11-29 |